Silicone-Based Prosthetic and Orthotic Liners with Antiperspirant and Methods of Forming the Same

Abstract

Liners are adapted for use with a prosthetic or orthotic device, and provide a barrier and/or interface between a residual limb and a prosthetic socket, or between an orthotic device and the site of application. The prosthetic and orthotic liners include at least one antiperspirant, and methods of forming the same in an efficient, reliable manner. The liners may include aluminum-based antiperspirants such as Aluminum Zirconium Tetrachlorohydrex Glycine. The antiperspirants may be provided as a powder or anhydride, may first be constituted in a silicone-oil, and mixed under vacuum. The antiperspirant-oil mixture can be combined with silicone components and mixed under vacuum. The resulting complete mixture is then cast and cured into a silicone elastomer liner with antiperspirant dispersed and/or embedded.

We claim: 
     
         1 . A method of manufacturing a liner for use with a prosthetic or orthotic device, comprising the steps of:
 combining an antiperspirant agent with a silicone oil to form a first mixture;   mixing the first mixture under vacuum to form a balanced mixture, wherein air is substantially removed from the first mixture during mixing, and wherein the balanced mixture comprises a combination of the antiperspirant agent and the silicone oil and from which air has been substantially removed;   adding at least one silicone component to the balanced mixture to form a second mixture;   mixing the second mixture under vacuum to form a complete mixture, wherein air is substantially removed from the second mixture during mixing, and wherein the complete mixture comprises a combination of the balanced mixture and the at least one silicone component and from which air has been substantially removed; and   curing the complete mixture to form a silicone product such that the antiperspirant agent is dispersed in the silicone product.   
     
     
         2 . The method of  claim 1 , wherein the antiperspirant agent is provided as a powder or anhydride. 
     
     
         3 . The method of  claim 1 , wherein the antiperspirant agent comprises an aluminum salt. 
     
     
         4 . The method of  claim 3 , wherein the aluminum salt comprises aluminum zirconium tetrachlorohydrex glycine. 
     
     
         5 . The method of  claim 1 , wherein the silicone product comprises a liner for use with a prosthetic or orthotic device, and wherein the liner is capable of reducing perspiration of a body part to which the liner is attached by at least 20% compared to a liner that does not include an antiperspirant agent dispersed therein. 
     
     
         6 . The method of  claim 1 , wherein the silicone product is configured for attachment to an amputated residual upper or lower limb. 
     
     
         7 . A liner for use with a prosthetic or orthotic device, comprising:
 an antiperspirant dispersed in carrier material, wherein:   the carrier material is configured for attachment to a body part;   the carrier material and antiperspirant are configured to permit the antiperspirant to leach from the carrier material and onto the body part to which the carrier material is attached; and   the antiperspirant is capable of reducing perspiration of the body part to which the carrier material is attached by at least 20% compared to a carrier material that does not include an antiperspirant dispersed therein.   
     
     
         8 . The liner of  claim 7 , wherein the dispersion of the antiperspirant in the carrier material is substantially uniform. 
     
     
         9 . The liner of  claim 7 , wherein the antiperspirant is configured to reduce perspiration by associating with moisture, entering a sweat gland duct cell, and causing said cell to swell, thereby limiting an amount of perspiration that can be secreted from a sweat gland. 
     
     
         10 . The liner of  claim 7 , wherein the antiperspirant comprises a hygroscopic substance. 
     
     
         11 . The liner of  claim 7 , wherein the antiperspirant comprises an aluminum-based compound. 
     
     
         12 . The liner of  claim 11 , wherein the aluminum based compound comprises an aluminum salt. 
     
     
         13 . The liner of  claim 12 , wherein the aluminum salt comprises aluminum zirconium tetrachlorohydrex glycine. 
     
     
         14 . The liner of  claim 7 , wherein the carrier material is capable of elastic attachment to the body part. 
     
     
         15 . The liner of  claim 7 , wherein the carrier material comprises a silicone-based compound. 
     
     
         16 . The liner of  claim 7 , wherein the carrier material comprises a cured two-component silicone-based compound. 
     
     
         17 . The liner of  claim 7 , wherein the carrier material and antiperspirant are configured to permit the antiperspirant to leach from the carrier material and onto the body part to which the carrier material is attached over an extended period of time. 
     
     
         18 . The liner of  claim 7 , wherein the body part comprises an amputated residual upper or lower limb. 
     
     
         19 . A liner for use with a prosthetic or orthotic device configured for being worn by a body part, comprising:
 a liner body portion formed from an elastomeric material;   an antiperspirant incorporated and/or embedded in the elastomeric material of the liner body portion in a substantially uniform manner, and configured to permit the antiperspirant to leach from the liner body portion and onto the body part wearing the liner; and   wherein the antiperspirant is capable of reducing perspiration of the body part to which the carrier material is attached by at least 20% compared to the elastomeric material that does not include an antiperspirant dispersed therein.   wherein the antiperspirant is selected from the group consisting a hygroscopic substance, and an aluminum-based compound.   
     
     
         20 . The liner of  claim 19 , wherein the carrier material comprises a silicone-based compound.